[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569016":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":75,"collaborators":79,"id":96,"slug":25,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":25,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery plus low dose radiotherapy","EXPERIMENTAL","Surgery:\n\nEndoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.\n\nRetropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy.\n\nRadiotherapy:\n\nLow Dose Raiotherapy:\n\nLow dose radiotherapy target area: CTV1: tumor bed area; For cases where the margin of the primary lesion is negative but less than 3mm, the margin area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT\u002FMRI, regardless of size; CTV2: Low risk infiltration area.\n\nIntensity modulated radiation therapy prescription dose: CTV1: 36.00Gy\u002F15Fr\u002F2.40Gy; CTV2: 30.00Gy\u002F15Fr\u002F2.00Gy.",[13],"Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgery","Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.\n\nRetropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy.\n\nBilateral Upper Neck Lymph Node Dissection: the specific cleaning area is the lymph nodes upon the Hyoid bone regions.",[13,18],"Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy","in experimental arm 1",[15,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection","in experimental arm 2",[15],[31],{"name":32,"affiliation":33,"role":34},"Ming-Yuan Chen, MD,PhD","SUN yet-sen University","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+8613903052650","chmingy@email.sysu.edu.cn",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"You-Ping Liu, PhD","+8613751763276","liuyp78@email.sysu.edu.cn",[45,63],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The Fifth Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","516000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],113.25,23.11667,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":38,"phoneExt":25,"email":62},"Mingyuan Chen, PhD.","chmingy@mail.sysu.edu.cn",{"facility":64,"status":47,"city":65,"state":49,"zip":66,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"The Fifth Affiliated Hospital of Sun Yat-sen University","Zhuhai","519000",{"type":54,"coordinates":68},[69,70],113.56778,22.27694,{"lat":70,"lon":69},[73],{"name":74,"role":37,"phone":42,"phoneExt":25,"email":43},"Youping Liu, PhD.",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Ming-Yuan Chen","Professior,Chief physician",[80,82,84,86,88,90,92,94],{"name":81,"class":6},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"name":83,"class":6},"Sun Yat-Sen University Cancer Center",{"name":85,"class":6},"Fifth Affiliated Hospital of Guangzhou Medical University",{"name":87,"class":6},"Huazhong University of Science and Technology Union Shenzhen Hospital",{"name":89,"class":6},"Nanfang Hospital, Southern Medical University",{"name":91,"class":6},"First Affiliated Hospital, Sun Yat-Sen University",{"name":93,"class":6},"First People's Hospital of Foshan",{"name":95,"class":6},"Zhongshan People's Hospital, Guangdong, China","100569016",false,"NCT06688760","Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma","Endoscopic Nasopharyngectomy Combined with Retropharyngeal Lymph Node Dissection Plus Low-dose Radiotherapy Versus Bilateral Upper Neck Dissection for Newly Diagnosed Stage I Nasopharyngeal Carcinoma: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nInclusion Criteria:\n\n* Performance Status Score 0-1 points.\n* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and\u002For cytologically.\n* According to the UICC\u002FAJCC eighth edition staging, the patient is defined as T1N0M0 stage I.\n* Adequate organ function: WBC ≥ 4×10\\^9 \u002FL, NEUT ≥ 2×10\\^6 \u002FL, HGB ≥ 9 g\u002FdL, PLT count ≥ 100×10\\^9\u002FL, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g\u002FdL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL\u002Fmin.\n* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.\n\nExclusion Criteria:\n\n* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.\n* Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.\n* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.\n* During pregnancy or lactation.\n* Other patients that the chief physician considered as illegal for this trial.","ALL","18 Years","70 Years",{"count":106,"type":107},86,"ESTIMATED","INTERVENTIONAL",[110],"NA","The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.",[113,15,114],"Nasopharyngeal Carcinoma","Radiotherapy","2024-11-12",{"date":117,"type":118},"2024-11-14","ACTUAL",{"date":120,"type":118},"2023-11-01",{"date":122,"type":107},"2028-11-01",{"name":77,"class":6},2]